Mild Cognitive ImpairmentNCT05448768
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI
A study testing TBS for Amyloid-positive MCI and TBS for Amyloid-negative MCI in people with Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- TBS for Amyloid-positive MCI and TBS for Amyloid-negative MCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Sep 2022to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 50-90 year
- Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
- The CDR of MCI patients can be 0-0.5
- Amyloid PET should ever be performed
Who cannot join
- Any subject has a definite diagnosis of epilepsy or history of seizure attack.
- Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
- Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
- Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
- Any females who is pregnant or lactating.
- General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.
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- Withdrawal criteria
- Complications onset after intervention that affect efficacy and safety judgments.
- New onset or progression of disease that may affect outcomes.
- Use of other therapies or drugs during the intervention period to change cognitive functions.
- Any subjects who are recognized as high risk of adverse effects by principle investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)
This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).
Read the detailed description
The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.
- Conditions
- Mild Cognitive Impairment
- Being tested
- TBS for Amyloid-positive MCI, TBS for Amyloid-negative MCI
- Keywords
- Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBS for Amyloid-positive MCIDevice
The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
TBS for Amyloid-negative MCIDevice
The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Amyloid-positive MCI | Active comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. Receives: Device: TBS for Amyloid-positive MCI |
| Amyloid-negative MCI | Active comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. Receives: Device: TBS for Amyloid-negative MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination ( MMSE )
Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention
Measured: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Montreal Cognitive Assessment
Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention
Measured: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS
Secondary outcomes (1)
The standard uptake values changes of FDG-PET
The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET
Measured: Before and immediately after TBS intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start13 Sep 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KUAN YI WU, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448768
- Sponsor's protocol ID
- 202102037A3A0
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No